NTP 9th RoC - call for public comments on agents

http://ntp.niehs.nih.gov/go/8185

[Federal Register: December 14, 1998 (Volume 63, Number 239)]
[Notices]
[Page 68783 - 68785]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program

National Toxicology Program; Call for Public Comments on 11 Agents, Substances, Mixtures and Exposure Circumstances Proposed for Listing in or Delisting from the Report on Carcinogens, Ninth Edition

Background

The National Toxicology Program (NTP) solicits final public comments on additional agents, substances, mixtures and exposure circumstances for listing in or delisting from the Report on Carcinogens, Ninth Edition. This Report is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens and the Secretary, Department of Health and Human Services (HHS) delegates its preparation to the National Toxicology Program. Section 301 (b) (4) of the Public Health Service Act, as amended, provides that the Secretary, (HHS), shall publish a report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States (US) are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.

In 1998, 11 substances or exposure circumstances were reviewed for listing in or removal from the Ninth Report. This review included two Federal and one non-government, scientific peer reviews and public comment and review. The three scientific review committees evaluated all available data relevant to the criteria for inclusion or removal of candidate substances or exposure circumstances in the Report. The criteria used in the review process and the detailed description of the review procedures, including the steps in the current formal review process, can be obtained by contacting: Dr. C. W. Jameson, National Toxicology Program, Report on Carcinogens, 79 Alexander Drive, Room 3217, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-2242, email: jameson@niehs.nih.gov. This information is also available on the NTP Home Page website at http://ntp.niehs.nih.gov/ntp/

Public Comment Requested

The NTP will be making a final recommendation in 1999 for the 11 substances or exposure circumstances reviewed in 1998, for either listing in, delisting from, or changing the current listing from reasonably anticipated to be a human carcinogen to the known to be a human carcinogen category in the Ninth Report. These nominated substances or exposure circumstances are provided in the following table with their Chemical Abstracts Services (CAS) Registry numbers (where available) and the recommendations from the three scientific peer reviews of the nominations.

Background documents provided to the review committees and the interested public are available upon request. The NTP will review the recommendations of each of the review committees and consider the public comments received throughout the process in making decisions regarding the NTP recommendations to the Secretary, DHHS, for listing or removal of the nominated substances and exposure circumstances in the Ninth Edition of the Report on Carcinogens. The NTP solicits final public comment to supplement any previously submitted comments or to provide comments for the first time on any substance or exposure circumstances in the following table. Comments will be accepted for a period of 60 days from the date of the publication of this announcement in the Federal Register. Comments or questions should be directed to Dr. C. W. Jameson at the address listed above.

Attachment

Dated: December 4, 1998

___________________________
Kenneth Olden, Ph. D.
Director
National Toxicology Program

[Billing Code 4140-01-P]

Summary of RG1¹, RG2² and NTP Board Subcommittee³ Recommendations
for the Agents, Substances, Mixtures or Exposure Circumstances Reviewed
in 1998 for Listing in or Delisting from the Report on Carcinogens⁴, 9th Edition

NOMINATION/ CAS NUMBER	PRIMARY USES OR EXPOSURES	RG1 ACTION	RG2 ACTION	NTP BOARD SUBCOMMITTEE ______ACTION______
Alcoholic Beverages	Consumption of alcoholic beverages	RG1 recommended (6 yes votes to 1 no vote) listing as known to be a human carcinogen.	RG2 unanimously recommended (7 yes votes to 0 no votes) listing as known to be a human carcinogen.	The Subcommittee recommended (9 yes votes to 3 no votes with 1 abstention) listing as known to be a human carcinogen.
Boot and Shoe Manufacture and Repair	Workers in the boot and shoe manufacture and repair industry	RG1 recommended (5 yes votes to 1 no vote) that Boot and Shoe Manufacture and Repair in the United States be included in the RoC as having been reviewed but not formally listed, due to inadequate data.	RG2 recommended (6 yes votes to 1 no vote) that Boot and Shoe Manufacture and Repair in the United States be included in the RoC as having been reviewed but not formally listed, due to inadequate data.	The Subcommittee unanimously recommended (10 yes votes to 0 no votes) to defer action on this nomination because of the lack of exposure assessment information.
Diesel Exhaust Particulates	Diesel engine exhaust	RG1 defeated a motion to list as reasonably anticipated to be a human carcinogen (4 yes votes to 5 no votes). RG1 recommended (5 yes votes to 4 no votes) to list as known to be a human carcinogen.	RG2 recommended (6 yes votes to 1 no vote) to list as reasonably anticipated to be a human carcinogen.	The Subcommittee recommended (9 yes votes to 0 no votes with 3 abstentions) to list as reasonably anticipated to be a human carcinogen.
Environmental Tobacco Smoke	"Passive" inhalation of tobacco smoke from environmental sources	RG1 recommended (7 yes votes to 0 no vote with 1 abstention) to list as known to be a human carcinogen.	RG2 recommended (5 yes votes to 2 no votes) to list as known to be a human carcinogen.	The Subcommittee unanimously recommended (13 yes votes to 0 no votes) listing as known to be a human carcinogen
Ethyl Acrylate / 140-88-5	Monomer used to produce polymers and copolymers for use in latex paints, textiles, etc.	RG1 recommended ( 7 yes votes to 2 no votes) to delist from RoC	RG2 recommended ( 6 yes votes to 1 no vote) to delist from RoC	The Subcommittee recommended (8 yes votes to 2 no votes with 2 abstentions) to delist from the RoC.
Ethylene Oxide/ 75-21-8	Industrial chemical used as an intermediate in the manufacture of other chemicals; e.g., ethylene glycol and is widely used in the health care industry as a sterilant.	RG1 recommended ( 6 yes votes to 1 no vote) to upgrade to a known human carcinogen	RG2 unanimously recommended (7 yes votes to 0 no votes) to upgrade to a known human carcinogen	The Subcommittee recommended (6 yes votes to 5 no votes with 1 abstention) to upgrade to a known human carcinogen
Isoprene/ 78-79-5	The monomeric unit of natural rubber and naturally occurring terpenes and steroids and widely used in the production of isoprene-butadiene copolymers.	RG1 unanimously recommended (6 yes votes to 0 no votes) to list as reasonably anticipated to be a human carcinogen.	RG2 recommended (6 yes votes to 0 no votes with 1 abstention) to list as reasonably anticipated to be a human carcinogen.	The Subcommittee unanimously recommended (13 yes votes to 0 no votes) to list as reasonably anticipated to be a human carcinogen.
Methyl-t-Butyl Ether/ 1634-04-4	Used as an additive in unleaded gasoline in amounts up to 11%.	RG1 recommended (4 yes votes to 3 no votes) to list as reasonably anticipated to be a human carcinogen^.	RG2 voted against motion to list as reasonably anticipated to be a human carcinogen (3 yes votes to 4 no votes)	The Subcommittee voted against motion to list as reasonably anticipated to be a human carcinogen (5 yes votes to 6 no votes with 1 abstention).
Nickel Compounds	Many industrial and commercial applications.	RG1 unanimously recommended (7 yes votes to 0 no votes) to upgrade to a known human carcinogen.	RG2 recommended (4 yes votes to 3 no votes with 1 abstention) to upgrade to a known human carcinogen.	The Subcommittee unanimously recommended (12 yes votes to 0 no votes) to upgrade to a known human carcinogen.
Silica, Crystalline (Respirable Size)/ 7631-86-9	Exposure from mining and quarrying of coal and other minerals, stone cutting, production of glass and ceramics and in occupations such as sandblasting, polishing and grinding.	RG1 unanimously recommended (9 yes votes to 0 no votes) to upgrade to a known human carcinogen.	RG2 recommended (5 yes votes to 2 no votes) to upgrade to a known human carcinogen.	The Subcommittee recommended (11 yes votes to 1 no vote) to upgrade to a known human carcinogen.
2,3,7,8- Tetrachlorodibenzo-p-dioxin (TCDD)/ 1746-01-6	Not used commercially, found as a contaminant in the production of some pesticides and other commercial products.	RG1 unanimously recommended (10 yes votes to 0 no votes) to upgrade to a known human carcinogen	RG2 unanimously recommended (8 yes votes to 0 no votes) to upgrade to a known human carcinogen	The Subcommittee voted against motion to upgrade current listing to known human carcinogen. (5 yes votes to 7 no votes with 1 abstention).

^{1 - The NIEHS Review Committee for the Report on Carcinogens (RG1)
^{2 - The NTP Executive Committee^* Interagency Working Group for the Report on Carcinogens (RG2)

^{*Agencies represented on the NTP Executive Committee include: Agency for Toxic Substances and Disease Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), National Institute for Occupational Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), National Library of Medicine (NLM), and National Institute of Environmental Health Sciences/NTP (NIEHS/NTP)}

^{3 - The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (the External Peer Review Group)
^{4 – RoC – Report on Carcinogens}}}}

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